Case Study: A Dual-Platform Potency Assay Strategy for Multivalent LNP-mRNA Vaccines

Download our case study, A Dual-Platform Potency Assay Strategy for Multivalent LNP-mRNA Vaccines, to explore how combining orthogonal potency assays can provide a more comprehensive evaluation of mRNA vaccine performance. This resource outlines a dual approach leveraging total expression ELISA for drug substance (DS) and flow cytometry for drug product (DP), enabling assessment of both mRNA translation efficiency and LNP-mediated delivery and antigen localization. It also highlights key technical challenges, such as LNP handling variability and flow cytometry complexity, and offers practical strategies to improve assay robustness, throughput, and data clarity. Additionally, the case study presents a comparative analytical framework to help guide assay selection and support scalable, regulatory-ready potency programs for advanced mRNA therapeutics.